MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER

Model Number	CRUOS106
Medical Device Problem Codes	Overheating of Device (1437); Material Separation (1562); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number was provided, a lot history review will be performed.The return of the sample is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruos106, recanalization catheter, allegedly experienced an overheating issue.This information was received from a single source.This malfunction involved a (b)(6) year old female patient with no consequences.The patient's weight was not provided.
Additional Manufacturer Narrative
H10: as the lot number was provided, a lot history review will be performed.The sample was returned for evaluation and material separation was identified.Overheating of device was unable to be identified.A root cause could not be determined.The device is labeled or single use.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruos106, recanalization catheter, allegedly experienced an overheating issue.This information was recieved from a single source.This malfunction involved a 90 year old female patient with no consequences.The patient's weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruos106, recanalization catheter, allegedly experienced an overheating issue and twisted.This information was recieved from a single source.This malfunction involved a 90 years old female patient with no consequences.The patient's weight was not provided.
Additional Manufacturer Narrative
The lot number was provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.Therefore, the investigation of the reported malfunction was confirmed for twisting and separation; while inconclusive for overheating.Based upon the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9591783
• Report Number: 2020394-2020-00300
• Device Sequence Number: 2474388
• Product Code: PDU
• UDI-Device Identifier: 10801741125611
• UDI-Public: (01)10801741125611
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CRUOS106
• Device Catalogue Number: CRUOS106
• Device Lot Number: GFDT1757
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020; 06/29/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/06/2020; 07/16/2020
• Patient Sequence Number: 1